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Phase 3 study of perioperative dostarlimab in participants with untreated T4N0 or stage III dMMR/MSI-H resectable colon cancer
EU CTIS ID: 2023-503265-27-00
What this study is testing
The Primary objective is to evaluate the efficacy of peri-operative dostarlimab compared with standard of care in participants with untreated T4N0 or Stage III (resectable), dMMR/MSI-H colon cancer.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Is at least 18 years of age.
- Has an ECOG- PS of 0 or 1.
- Has adequate organ function.
- Has untreated pathologically confirmed colon adenocarcinoma.
- Has resectable colon adenocarcinoma defined as clinically T4N0 or Stage III.
- Has radiologically evaluable disease.
You likely can't join if
- Has distant metastatic disease.
- Is immunocompromised.
- Has documented presence of HBsAg at Screening or within 3 months prior to randomization.
- Has an active autoimmune disease that has required systemic treatment in the past 2 years.
- Has experienced any of the following with prior immunotherapy: any irAE ≥ Grade 3, immune-mediated severe neurologic events of any-grade (e.g., myasthenic syndrome/myasthenia gravis, encephalitis, Guillain-Barré Syndrome, or transverse myelitis), exfoliative dermatitis of any grade (SJS, TEN, or DRESS syndrome), or myocarditis of any grade.
- Has undergone any major surgical procedure, open biopsy, or experienced significant traumatic injury within 28 days prior to enrollment.
See the full eligibility criteria
- Is at least 18 years of age.
- Has an ECOG- PS of 0 or 1.
- Has adequate organ function.
- Has untreated pathologically confirmed colon adenocarcinoma.
- Has resectable colon adenocarcinoma defined as clinically T4N0 or Stage III.
- Has radiologically evaluable disease.
- Has a tumor demonstrating the presence of either a dMMR status or MSI-H phenotype.
- Participants who are known to have Lynch syndrome and have been found to carry a specific germline mutation in an MMR gene (MLH1, MSH2, MSH6, PMS2) or EPCAM gene may be eligible to participate.
- Provides a tumor tissue sample obtained at the time of or after the initial diagnosis of colon cancer.
- Is willing to use adequate contraception.
- Can provide a signed informed consent.
- Has distant metastatic disease.
- Is immunocompromised.
- Has documented presence of HBsAg at Screening or within 3 months prior to randomization.
- Has an active autoimmune disease that has required systemic treatment in the past 2 years.
- Has experienced any of the following with prior immunotherapy: any irAE ≥ Grade 3, immune-mediated severe neurologic events of any-grade (e.g., myasthenic syndrome/myasthenia gravis, encephalitis, Guillain-Barré Syndrome, or transverse myelitis), exfoliative dermatitis of any grade (SJS, TEN, or DRESS syndrome), or myocarditis of any grade.
- Has undergone any major surgical procedure, open biopsy, or experienced significant traumatic injury within 28 days prior to enrollment.
- Has a history of congenital long QT syndrome.
- Has a history of or evidence of cardiac abnormalities.
- Is receiving any other anticancer or experimental therapy.
- Is receiving immunosuppressive medication.
- Has received systemic corticosteroids (>10 mg daily prednisone or equivalent) within 7 days of first dose of study intervention.
- Has received any live vaccine within 30 days of enrollment.
- Has a positive HCV antibody test result at Screening Visit or within 3 months prior to randomization.
- Has a positive HCV RNA test result at Screening Visit or within 3 months prior to randomisation.
- Is pregnant, breastfeeding, or expecting to conceive children within the projected duration of the study, starting with the Screening Visit through 9 months after the last dose of study intervention.
- Has any condition that would exclude the patient from chemotherapy with FOLFOX or CAPEOX.
- Has any history of interstitial lung disease /pneumonitis and/or radiation induced enteritis. Has cirrhosis or current unstable liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal/gastric varices, or persistent jaundice.
- Has a history or current evidence of any medical condition, therapy, or laboratory abnormality that might confound the study results, interfere with their participation for the full duration of the study intervention, or indicate it is not in the best interest of the participant to participate.
- Has a history of allogenic stem cell transplantantion or organ transplantation.
- Has received prior medical therapy, radiation therapy or surgery for management of the current diagnosis of colon cancer.
- Has a tumor that is causing symptomatic bowel obstruction or otherwise requires urgent/emergent surgery at the time of screening. Participants with a history of colonic obstruction are eligible after obstruction is relieved by a diverting stoma (defunctioning ileostomy or colostomy).
- Has a tumor that is not amenable to surgery or has any other contraindication to surgery.
- Has a known additional malignancy that progressed or required active treatment within the past 2 years.
The study team makes the final eligibility decision.
Where it's taking place
- Taiwan
- United Kingdom
- Turkey
- Panama
- Brazil
- Argentina
- China
- United States
- Mexico
- Korea, Republic of
- Australia
- Japan
- India
- Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Taiwan; United Kingdom; Turkey; Panama; Brazil; Argentina and 8 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.